Clinical Research Coordinator (RN) - Oncology
Job Description
Responsible for the performance of the research study under the medical supervision of the Principal Investigator. Clinical Research Coordinator III (RN) performs tasks independently, consistently and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work.
Key Performance Areas
KPA 1 – Protocol Comprehension and Implementation: Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements. Demonstrate an understanding of protocol elements / requirements and demonstrate the ability to execute study procedures. Demonstrate the ability to anticipate and mitigate the potential for protocol non-compliance.
KPA 2 – Regulatory and Data Integrity: Understanding of the IRB/IEC review, key elements of review considerations, approval and reporting requirements for the site. Complete all IRB/IEC-related documents over the course of a clinical study. Maintain site credentials and ensure updated GCP, licenses remain on file. Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC. Autonomously collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy. Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials. Manage a monitoring visit including appropriate preparations, support, documentation and follow up. Maintain proper (accurate and timely) communication with the monitor and follow up on all monitor requests. Implement a CAPA assessment and follow CAPA related issues through to resolution. Escalates issues of protocol non-compliance to study PI and research department leadership.
KPA 3 – Research Financial Practices: Budget/Contract execution and practices research billing compliance. Assess a protocol and study plan to develop a study budget. Understanding of the payment terms of the study budget and the and tract items that need to be invoiced for a clinical study.
Position Qualifications/Requirements
Education: Bachelors or Associates degree in Nursing is required.
Certifications/Licenses: Unencumbered RN License in state of employment or multi-state license. Valid state Driver’s License for travel to satellite offices and offsite meetings. Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required.
Previous Experience: 2-5 years nursing experience required, oncology preferred.
Core Capabilities
Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.
Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters. Communicate effectively (oral, written, presentation), be an active listener, and effectively provide balanced feedback.
Communication Skills: Good command of the English language. Second language is an asset but not required.
Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.
Self-Management: Effectively manage own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required. Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.
Computer Skills: Proficiency in MS Office Word, Excel, Power Point, and Outlook required. Prior experience with electronic medical records (EMR) is preferred. Prior experience with clinical trial data entry systems (EDC) preferred. Prior Clinical Trial Management Systems (CTMS) preferred.
Travel
0%
Standard Core Workdays/Hours
Monday to Friday 8:00 AM – 5:00 PM